InfectionsNCT01153191
Effectiveness for Interventions to Minimize Surgical Site Infections
A study testing Normal saline pressurized irrigation and sub-q gentamicin in people with Infections, run by Dallas VA Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate two different simple and inexpensive extra treatments during colorectal surgeries to see if this will reduce the rate of post operative infections Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Infections
- What is being tested?
- Normal saline pressurized irrigation and sub-q gentamicin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- VA patients getting transabdominal,elective colorectal procedures
- willing and capable of giving self informed consent
Who cannot join
- patients unable to give informed consent
- emergency colorectal procedures
- transanal procedures
- patients who have contaminated or dirty wounds that would preclude attempts at skin closure at the conclusion of the procedure
- patients undergoing appendectomy
- patients undergoing intraabdominal procedures not including surgical resection of the colon or rectum (ie.procedures involving small bowel , stomach)
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- patients with pre/op creatinine clearance less than 20ml/min
- patients with known allergy or hypersensitivity to gentamicin
- patients that have received gentamicin within 2 weeks of potential study date
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing Evidence of Effectiveness for Adjuvant Interventions Designed to Minimize Surgical Site Infections
The purpose of this study is to evaluate two different simple and inexpensive extra treatments during colorectal surgeries to see if this will reduce the rate of post operative infections
Read the detailed description
The population for inclusion for this study will be drawn from the patients undergoing elective transabdominal colorectal surgery. This population was chosen due to its inherently high rate of superficial-incisional infection.Colorectal procedures stand out as a particularly highrisk surgery with respect to SSI. Several studies have reported rates of infection of 25% or more making colorectal surgeries an excellent opportunity for testing new strategies to reduce SSI.
This pilot project seeks to preliminarily evaluate two new strategies that are inexpensive and could be readily incorporated into current practice. The strategies are pressurized irrigation of the superficial surgical wound (above the fascia) and subcutaneous injection of gentamicin into the surgical wound prior to initial skin incision. Comparison will be made between prospectively enrolled patients and historic controls.The hypothesis to be tested is that these interventions will significantly reduce superficial incisional infection rates compared with historic control.
- Conditions
- Infections
- Being tested
- Normal saline pressurized irrigation, sub-q gentamicin
- Keywords
- colorectal surgery
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal saline pressurized irrigationProcedure or surgery
Also called 1st group
same
sub-q gentamicinDrug
Also called 2nd group
2mg/kg of gentamicin in 20 ml of sterile saline up to max dose of 120mg injected above the abdominal wall fascia- the length of the incision will be marked and injection made with intent being to evenly distribute the volume of injection in the subcutaneous tissues in immediate vicinity of and prior to the initial incision- analogous to the technique employed when using local anesthetic
| Study group | Role | What they receive |
|---|---|---|
| Pressurized irrigation | Experimental | first group-After closure of patients abdominal wall fascia, Hydrostatic irrigation with 3 liters of normal saline with Simpulse Solo irrigation system (Davol) at less than 15PSI will be applied to subcutaneous tissues prior to closure Receives: Procedure: Normal saline pressurized irrigation |
| Sub Q Antibiotic | Experimental | second group of patients will receive 2mg/lg of gentamicin in 20 ml of sterile saline injected into the superficial tissues above the ABD wall fascia prior to initial incision Receives: Drug: sub-q gentamicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection rate in colorectal surgeries in each of two treatment arms as compared to historic controls
pilot study to evaluate 1. pressurized irrigation of the superficial surgical wound after fascial closure in 40 patients and 2. subcutaneous gentamicin into the surgical area prior to initial incision in 40 patients and compare rates of surgical site infections after 30 days to historic controls.
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2010 (estimated)
- Study startAug 2010
- Primary completionSep 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dallas VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Thomas Anthony, Dallas VA Medical Center
- Investigators
- Sean Dineen, MD, Principal investigator, VANTXHCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01153191
- Sponsor's protocol ID
- #10-046
- Status last verified
- Nov 2011
- First submitted
- 29 Jun 2010
- Last updated
- 4 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Dineen SP, Pham TH, Murray BW, Parker BJ, Hartless K, Anthony T, Huerta S. Feasibility of subcutaneous gentamicin and pressurized irrigation as adjuvant strategies to reduce surgical site infection in colorectal surgery: results of a pilot study. Am Surg. 2015 Jun;81(6):573-9.
PubMed 26031269
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Evidence of Effectiveness for Adjuvant Interventions Designed to Minimize Surgical Site Infections
- ClinicalTrials.gov ID
- NCT01153191
- Acronym / sponsor ID
- #10-046
- Conditions
- Infections
- Keywords
- colorectal surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Dallas VA Medical CenterUS federal agency
- Study start
- Aug 2010
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 30 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate two different simple and inexpensive extra treatments during colorectal surgeries to see if this will reduce the rate of post operative infections
Detailed description
The population for inclusion for this study will be drawn from the patients undergoing elective transabdominal colorectal surgery. This population was chosen due to its inherently high rate of superficial-incisional infection.Colorectal procedures stand out as a particularly highrisk surgery with respect to SSI. Several studies have reported rates of infection of 25% or more making colorectal surgeries an excellent opportunity for testing new strategies to reduce SSI.
This pilot project seeks to preliminarily evaluate two new strategies that are inexpensive and could be readily incorporated into current practice. The strategies are pressurized irrigation of the superficial surgical wound (above the fascia) and subcutaneous injection of gentamicin into the surgical wound prior to initial skin incision. Comparison will be made between prospectively enrolled patients and historic controls.The hypothesis to be tested is that these interventions will significantly reduce superficial incisional infection rates compared with historic control.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pressurized irrigation | Experimental | Procedure: Normal saline pressurized irrigationfirst group-After closure of patients abdominal wall fascia, Hydrostatic irrigation with 3 liters of normal saline with Simpulse Solo irrigation system (Davol) at less than 15PSI will be applied to subcutaneous tissues prior to closure |
| Sub Q Antibiotic | Experimental | Drug: sub-q gentamicinsecond group of patients will receive 2mg/lg of gentamicin in 20 ml of sterile saline injected into the superficial tissues above the ABD wall fascia prior to initial incision |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- VA patients getting transabdominal,elective colorectal procedures
- willing and capable of giving self informed consent
Key exclusion criteria (9 listed)
- patients unable to give informed consent
- emergency colorectal procedures
- transanal procedures
- patients who have contaminated or dirty wounds that would preclude attempts at skin closure at the conclusion of the procedure
- patients undergoing appendectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal saline pressurized irrigationAlso: 1st groupsame | Procedure or surgery | Pressurized irrigation |
| sub-q gentamicinAlso: 2nd group2mg/kg of gentamicin in 20 ml of sterile saline up to max dose of 120mg injected above the abdominal wall fascia- the length of the incision will be marked and injection made with intent being to evenly distribute the volume of injection in the subcutaneous tissues in immediate vicinity of and prior to the initial incision- analogous to the technique employed when using local anesthetic | Drug | Sub Q Antibiotic |
Primary outcome
Infection rate in colorectal surgeries in each of two treatment arms as compared to historic controls
Time frame: 30 days after surgery
pilot study to evaluate 1. pressurized irrigation of the superficial surgical wound after fascial closure in 40 patients and 2. subcutaneous gentamicin into the surgical area prior to initial incision in 40 patients and compare rates of surgical site infections after 30 days to historic controls.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2011.
- Derived from this study: PubMed 26031269Dineen SP, Pham TH, Murray BW, Parker BJ, Hartless K, Anthony T, Huerta S. Feasibility of subcutaneous gentamicin and pressurized irrigation as adjuvant strategies to reduce surgical site infection in colorectal surgery: results of a pilot study. Am Surg. 2015 Jun;81(6):573-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean Dineen, MD principal investigator
VANTXHCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal saline pressurized irrigation and sub-q gentamicin in people with Infections, run by Dallas VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection rate in colorectal surgeries in each of two treatment arms as compared to historic controls (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01153191, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2011.